FDA Enforcement Statistics, FY 2009 – 2015

December 4, 2016

BACKGROUND:

FDA recently published enforcement metrics for FY2015 . This practice began with the publication of FY2009 data. The metrics provides a high level overview of the number of enforcement actions including: injunctions, seizures, warning letters and recalls conducted by all FDA Centers. This posting will look at the data from the enforcement metrics in two ways:

First, we will address the data presented in the FY2015 slide deck. These data represent all centers of the FDA: Center for Drug Evaluation and Research (CDER), Center for Biologic Evaluation and Research (CBER), Center for Devices and Radiologic Health (CDRH), Center for Veterinary medicine (CVM), Center for Food Safety and Nutrition (CFSAN) and Center for Tobacco Products (CTP).

Second, we’ve developed additional graphs from data in FDA enforcement metrics published between 2009 through 2015 that address only CDRH (devices) and CDER (drugs). We look at trends over the entire time period for a selected set of actions. Data from CBER, CFSAN, CVM and CTP are not included. CBER is not included because the majority of enforcement actions are taken against blood and plasma entities. The figures in this section are not published in the FDA metrics although the data come from those metrics.

CONCLUSIONS based on FDA FY2015 Enforcement Metrics: Each conclusion references the slide number(s) in the FDA deck.

The total number of product seizures is down to 1 in FY2015 (only CDER) from a high of 15 in FY2011. The number of seizures decreased consistently since 2011. (Slide 2 and 3)

FDA Injunctions more than doubled to 21 in FY 2015 from 10 in 2014 and is higher than it’s been in the entire 2010-2015 time period. CFSAN was associated with 12 of the 21 injunctions, CDRH with 4, CDER with 2 and CVM with 2. CBER and CTP had none. (Slides 4 and 5)

The number of warning letters from the Center for Tobacco Products dwarfs those issued from all other Centers, and has since 2011. This year warning letters are distributed as follows: CTP (16,629), CFSAN (236), CDRH (168), CVM (119), CDER (76), and CBER (4). Note that these include ALL warning letters, not just those issued for GMP deficiencies. (Slide 6)

The Center for Tobacco Products issued 97% of all FDA warning letters in FY2015, and the total number issued from CTP doubled over the number of warning letters they issued in FY2014. (Slide 6 and 7)

CDRH had the highest number of recall events with 1175 followed by CBER with 651, CFSAN with 621, CDER with 303 and CVM with 38. CTP had one recall for the year. (Slide 8)

CFSAN led with the number of Class I recalled products, followed by CDRH, CVM, CDER and CBER. (Slide 12)

CDRH led the number of Class II recalled products followed by CDER, CFSAN, CBER, CVM and CTP. (Slide 13)

CONCLUSIONS based on FDA data from 2009 – 2014 for CDER and CDRH.

As mentioned in the Background section, data used to construct the Figures below are taken directly from the FDA slide decks of enforcement actions from 2009 through 2014. The figures do not, however, appear in the FDA slide decks.

Figure 1 show the combined number of injunctions associated with CDER and CDRH increased between 2009 and 2013, but decreased in 2014 and rose to a new high in 2015. Overall, the numbers have increased since 2009 with an apparent dip in 2014.

Figure 1 also shows the combined number of product seizures associated with CDER and CDRH decreased between 2010 and 2013 but increased slightly in 2014 and decreased again in 2015 to the level seen in 2013. The number of seizures are low, less than or equal to five, and don’t readily allow identification of trends.

Figure 2 shows the number of warning letters issued by CDRH increased slightly between 2010 thru 2013 (with a dip in 2011), followed by a dramatic decrease in FY2014 and an increase in 2015, though the total remain below the number issued in 2010. Warning letters issued by CDER decreased from their peak in 2010 with another decrease in 2015. Please note theses are not exclusively GMP warning letters but include ALL warning letters issued by the specific Center.

Figure 3 presents the total CDER recalls events and shows no obvious trend over the period 2009 – 2015. The number of recalled products continues to outnumber the number of recall events. The number of recalled products has remained reasonably constant except for 2010 and 2013 where number were down by approximately 35%.

Figure 4 shows the number of Class I CDER recall events has gradually increased from 2009 through 2014 and then fell in 2015. The number of products subject to a Class I recall in each year reached a high point in 2010, decreased in each of the next two years and then increased so that the number for 2014 was essentially the same as in 2010. In 2015 the numbers of both recall events and recalled products decreased from 2014. Reference is made to a previous blog entry that addresses recalls of parenterals for the presence of foreign particulates between 2011 and 2015.

Figure 5 shows that total CDRH recall events have remained reasonably consistent from 2011 through 2014. The number of CDRH recalled products increased from 2009 through 2011, then decreased until 2013 only to increase again in 2014 and 2015.

Figure 6 shows the number of CDRHClass I products subject to recalls increased from 2009 through 2011, decreased significantly in 2012, increase again through 2014 and fell in 2015. The number of Class I recall events per year has consistently hovered at approximately 50.

The question often arises as to whether Class I recalls as a percentage of total recalls is increasing over time. When considering only CDER Class I recall events as a percentage of the total CDER recall events, Figure 7 shows that values from 2009 through 2013 varied between 9% and 14%. In 2014, the value increased significantly to 21% then fell in 2015.

The question often arises as to whether Class I recalls as a percentage of total recalls is increasing over time. When considering only CDRH Class I recall events as a percentage of the total of CDRH recall events, Figure 8 shows that values remain consistent between 4% and 6%. For CDRH Class I recall products as a percentage of total CDRH recalled products, the values between 2012 and 2014 clearly show an increasing trend but decreases in 2015. The value in 2014 however, is essentially the same as in 2010 and 2011. This may simply represent normal variability given small numbers but it is something we will monitor in the future.

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